Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by University of Texas Southwestern Medical Center.
Recruitment status was:  Available
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00765557
First received: September 30, 2008
Last updated: October 2, 2008
Last verified: October 2008

September 30, 2008
October 2, 2008
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

We hypothesize fecal retention is the primary source of bladder dysfunction in some children with Urge Syndrome. Our specific aims are:

  1. To test this hypothesis through a prospective, randomized, double-blinded and placebo-controlled trial of laxatives for children diagnosed with US.
  2. To determine if a validated questionnaire of bowel activity administered to the family, and when appropriate, the patient, will identify those likely to benefit from laxative therapy for bladder dysfunction.
  3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment of fecal loading corresponds to answers on the questionnaire regarding incidence of constipation, and/or response to laxative therapy for US.
Not Provided
Expanded Access
Not Provided
Not Provided
Urge Syndrome
Drug: Miralax
Every subject will be given one bottle of the laxative/placebo, and depending on the patient's weight, will be instructed to take 1-3 tsps (.75 gm/kg) of the medication daily.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • Toilet-trained with a history of urinary tract infection; vesicoureteral reflux; urinary incontinence; daily frequency and urgency; and diurnal incontinence.

Exclusion Criteria:

  • Children who are below 4 years old as they may still not be toilet-trained; children with encopresis; children with anorectal malformations; and children with neurologic disorders.
Both
4 Years to 21 Years   (Child, Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00765557
122004-038
Not Provided
Not Provided
Not Provided
Warren T. Snodgrass, M.D., University of Texas Southwestern Medical School
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP